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The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Reyataz® so that the regulatory authority can manage the marketing approval properly
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients ≥ 13 years of age with HIV-1 | Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Drug | Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events occurrence | Incidence (per person-time) and confidence interval of overall adverse events and each adverse event will be computed per surveillance period | 30 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) level before and after drug administration | Baseline and 16 weeks after first treatment | |
| CD 4 T-cell count before and after drug administration | Baseline and 16 weeks after first treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥ 13 years of age with HIV-1 who are on Reyataz® treatment at the time of enrollment and have never been participated in this study previously or who are initiating Reyataz® treatment for the first time in the real-life conditions in its registered indication(s) as required by KFDA
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Seoul | 110-756 | South Korea |
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| Overall efficacy evaluation by investigator's discretion | Based on laboratory test results including HIV RNA (viral load) and CD4 T-cell count, clinical findings, subjective findings and objective findings in comparison to baseline | Baseline and 16 weeks after first treatment |